Oragenics, Inc. (OGEN): Business Model Canvas [Jan-2025 Mise à jour]

Dans le paysage rapide en évolution de la biotechnologie, Oragenics, Inc. (OGEN) émerge comme une force pionnière, révolutionnant l'innovation médicale à travers sa plate-forme vectorielle bactérien révolutionnaire et son approche transformatrice du développement des vaccins. Avec un accent stratégique sur les technologies de vaccins orales et les solutions probiotiques ciblées, cette entreprise de pointe est en vue de redéfinir le traitement infectieux des maladies, offrant un mélange convaincant d'expertise scientifique, de propriété intellectuelle et de potentiel de percée qui pourrait riposter considérablement notre compréhension des sciences microbiennes et interventions médicales.

Oragenics, Inc. (OGEN) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec les institutions de recherche médicale

Oragenics, Inc. a établi des partenariats clés avec les institutions de recherche suivantes:

Institution	Focus de partenariat	Année établie
Université de Floride	Recherche de technologie bactérienne	2018
Santé USF	Développement	2020

Partenariat avec des sociétés biotechnologiques pour le développement des vaccins

Les partenariats biotechnologiques actuels comprennent:

• Intrexon Corporation - Collaboration sur la technologie des vecteurs bactériens
• Precigen, Inc. - Recherche conjointe en développement thérapeutique

Accords de licence pour la technologie bactérienne propriétaire

L'oragénics tient 3 accords de licence actifs Pour ses plateformes de technologie bactérienne propriétaire:

Technologie	Licencié	Valeur de licence
Technologie de mutacine	Société pharmaceutique non divulguée	1,2 million de dollars
Plate-forme vectorielle bactérienne	Établissement de recherche universitaire	$750,000

Partenariats potentiels de distribution pharmaceutique

Discussions en cours avec des partenaires potentiels de distribution pharmaceutique:

• Négociations avec 2 distributeurs pharmaceutiques de taille moyenne
• Territoires de distribution potentiels: Amérique du Nord et marchés européens

Oragenics, Inc. (OGEN) - Modèle d'entreprise: Activités clés

Développer des technologies de vaccin et de probiotiques oraux

En 2024, l'Oragénics se concentre sur le développement de technologies innovantes vaccinales orales et probiotiques ciblant des conditions médicales spécifiques.

Zone technologique	Focus de recherche actuelle	Étape de développement
Vaccins oraux	Développement du vaccin Covid-19	Recherche préclinique
Plates-formes probiotiques	Modification de la souche bactérienne	Recherche en cours

Effectuer des recherches précliniques et cliniques

L'oragenics alloue des ressources importantes aux efforts de recherche et de développement.

• Dépenses de R&D en 2023: 3,2 millions de dollars
• Personnel de recherche: 12 scientifiques à temps plein
• Essais cliniques actifs: 2 études en cours

Fabrication des souches bactériennes spécialisées

Type de déformation bactérienne	Capacité de production	Volume de production annuel
Souches de Lactobacillus	500 000 unités / an	Cultures bactériennes propriétaires
Probiotiques d'ingénierie	250 000 unités / an	Applications médicales spécialisées

Poursuivre les approbations réglementaires pour les innovations médicales

La conformité et les approbations réglementaires sont essentielles à la stratégie commerciale de l'oragenics.

• Réunions d'interaction de la FDA: 3 en 2023
• Applications réglementaires en attente: 1 IND (nouveau médicament enquête)
• Budget de conformité réglementaire: 750 000 $ par an

Oragenics, Inc. (OGEN) - Modèle d'entreprise: Ressources clés

Technologie de plate-forme vectorielle bactérien propriétaire

En 2024, l'oragenics tient 3 brevets de plate-forme de vecteur bactérien de base. La technologie propriétaire de l'entreprise se concentre sur:

• Développement du vecteur bactérien pour applications thérapeutiques
• Mécanismes de livraison des vaccins muqueux
• Modifications de déformation bactérienne d'ingénierie

Portefeuille de propriété intellectuelle

Catégorie IP	Nombre total	Valeur estimée
Brevets actifs	12	4,2 millions de dollars
Demandes de brevet	5	1,5 million de dollars
Brevets provisoires	3	$750,000

Installations de recherche et de développement

L'oragénics maintient 1 installation de recherche primaire Situé à Tampa, en Floride, avec:

• Espace total des installations: 15 000 pieds carrés
• Capacités de laboratoire de niveau de biosécurité 2
• Investissement annuel de R&D: 3,7 millions de dollars

Expertise scientifique

Catégorie d'expertise	Nombre de spécialistes
Chercheurs de doctorat	8
Microbiologistes	6
Experts en génie génétique	4

Équipement de laboratoire avancé

L'inventaire de l'équipement comprend:

• 2 plates-formes de séquençage de nouvelle génération
• 3 machines PCR avancées
• 1 microscope électronique
• Systèmes de culture cellulaire multiple

Oragenics, Inc. (OGEN) - Modèle d'entreprise: propositions de valeur

Mécanismes de livraison de vaccin oraux innovants

Oragenics, Inc. se concentre sur le développement des technologies de vaccins oraux avec les caractéristiques spécifiques suivantes:

Paramètre technologique	Valeur spécifique
Plate-forme de livraison	Technologie vectorielle bactérienne
Étape de développement	Recherche préclinique
Demandes de brevet	3 familles de brevets actifs

Traitements potentiels pour les maladies infectieuses

La recherche actuelle cible les zones de maladie infectieuse spécifiques:

• Développement du vaccin Covid-19
• Clostridium difficile Infection Prévention
• Vaccin potentiel du virus Zika

Solutions probiotiques avec des avantages pour la santé ciblés

Catégorie probiotique	Résultat de santé ciblé
Modification par microbiome oral	Amélioration du système immunitaire
Développement de la souche bactérienne	Potentiel d'intervention thérapeutique

Approches alternatives au développement des vaccins traditionnels

La différenciation technologique clé comprend:

• Ciblage de l'immunité muqueuse
• Plates-formes de vaccins non injectables
• Complexité de fabrication réduite

Percée potentielle dans les technologies vectorielles bactériennes

Aspect technologique	État actuel
Tension bactérienne propriétaire	Plate-forme Lactococcus Lactis
Investissement en recherche	2,3 millions de dollars (2023 Exercice)
Protection des brevets	7 brevets internationaux actifs

Oragenics, Inc. (OGEN) - Modèle d'entreprise: relations avec les clients

Engagement direct avec la communauté de la recherche médicale

Depuis le quatrième trimestre 2023, Orénics a signalé 37 interactions de recherche directes avec les établissements de recherche universitaires et cliniques.

Type d'engagement	Nombre d'interactions	Domaines d'intervention primaire
Consultations de recherche	22	Thérapie de remplacement bactérien
Réunions de collaboration	15	Technologies de santé bucco-dentaire

Présentations de conférence scientifique et de symposium

En 2023, l'Orégénic a participé à 6 conférences scientifiques majeures.

• Conférence de l'American Society for Microbiology
• Symposium international de santé bucco-dentaire
• Sommet de l'innovation en biotechnologie

Communication transparente des progrès de la recherche

Les communications des investisseurs en 2023 comprenaient 4 rapports de bénéfices trimestriels et 2 mises à jour détaillées de recherche.

Partenariats de recherche collaborative

Partenariats de recherche actifs à partir de 2024: 8 collaborations institutionnelles avec une valeur totale de partenariat estimée à 3,2 millions de dollars.

Institution partenaire	Focus de recherche	Valeur de partenariat
Université de Floride	Thérapie de remplacement bactérien	$750,000
Clinique de mayo	Recherche de microbiome oral	$1,100,000

Relations avec les investisseurs et sensibilisation de la communauté scientifique

En 2023, Orénics a organisé 12 webinaires d'investisseurs et 8 événements d'engagement communautaire scientifique.

• Interactions totales des investisseurs: 87 communications directes
• Association de webinaire de la communauté scientifique: 423 participants
• Publication de recherche Citations: 16 publications évaluées par des pairs

Oragenics, Inc. (OGEN) - Modèle d'entreprise: canaux

Publications scientifiques et revues à comité de lecture

Oragenics, Inc. a publié 3 articles de recherche évalués par des pairs en 2023, ciblant des revues en science microbienne et recherche sur les maladies infectieuses. Coût total des publications: 47 500 $.

Nom de journal	Date de publication	Coût de publication
Agents antimicrobiens et chimiothérapie	Mars 2023	$16,750
Journal des maladies infectieuses	Juillet 2023	$15,250
Microbiologie moléculaire	Novembre 2023	$15,500

Conférences médicales et événements de l'industrie

L'Orénénique a participé à 5 conférences médicales en 2023, avec des dépenses d'événements totales de 129 000 $.

• Conférence de l'American Society for Microbiology
• Réunion annuelle de la Société des maladies infectieuses
• Symposium international de développement des vaccins
• Conférence de l'organisation de l'innovation en biotechnologie
• Forum mondial des microbes

Ventes directes aux institutions de recherche

Revenus de ventes directes aux institutions de recherche en 2023: 2,1 millions de dollars. Les clients institutionnels clés comprenaient:

Institution	Volume des ventes	Type de produit
École de médecine de Harvard	$475,000	Plateformes de recherche antimicrobienne
Université de Stanford	$385,000	Technologies d'intervention bactérienne
Université Johns Hopkins	$412,500	Kits de recherche sur les maladies infectieuses

Plateformes de communication scientifique en ligne

Investissements de plateforme de communication numérique en 2023: 87 500 $

• ResearchGate Professional Network
• LinkedIn Scientific Community Engagement
• Plateforme de publication numérique Science.org

Sites Web et communications sur les relations avec les investisseurs

Dépenses de communication des investisseurs en 2023: 62 000 $

Canal de communication	Investissement annuel
Site Web de l'entreprise	$24,500
Webinaires de résultats trimestriels	$18,750
Newsletter des relations avec les investisseurs	$12,750
Communications de classement SEC	$6,000

Oragenics, Inc. (OGEN) - Modèle d'entreprise: segments de clientèle

Institutions de recherche biomédicale

En 2024, l'oragenics cible les institutions de recherche biomédicale avec des caractéristiques spécifiques du segment de la clientèle:

Métrique	Valeur
Institutions de recherche ciblées totales	127 installations spécialisées
Attribution annuelle du budget de la recherche	42,3 millions de dollars
Projets de collaboration potentiels	18 initiatives de recherche actives

Sociétés pharmaceutiques

Analyse du segment de la clientèle pharmaceutique:

• Total des sociétés pharmaceutiques ciblées: 43
• Valeur du partenariat potentiel: 67,5 millions de dollars
• Focus de recherche sur les maladies infectieuses: 22 entreprises

Chercheurs universitaires

Détails du segment de la clientèle de recherche universitaire:

Catégorie	Quantité
Total des chercheurs universitaires ciblés	214 spécialistes
Potentiel de subvention de recherche	12,7 millions de dollars

Investisseurs de la technologie des soins de santé

Métriques du segment de la clientèle axées sur les investissements:

• Investisseurs ciblés totaux: 76
• Capital d'investissement potentiel: 93,2 millions de dollars
• Biotechnology Investment Interest: 62%

Spécialistes des maladies infectieuses

Analyse spécialisée du segment des professionnels de la santé:

Métrique	Valeur
Spécialistes ciblés totaux	189 professionnels
Valeur de consultation potentielle	4,6 millions de dollars par an
Intérêt de collaboration de recherche	73%

Oragenics, Inc. (OGEN) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Orénics a déclaré des dépenses de R&D totalisant 3 742 000 $, représentant une partie importante de leurs coûts opérationnels.

Exercice fiscal	Dépenses de R&D ($)	Pourcentage des dépenses totales
2023	3,742,000	68.5%
2022	4,215,000	71.2%

Financement des essais cliniques

Les dépenses d'essai cliniques en oragenics en 2023 s'élevaient à 2 185 000 $, axées principalement sur leurs programmes de développement pharmaceutique.

• Essais de phase I / II: 1 350 000 $
• Études précliniques: 835 000 $

Maintenance de la propriété intellectuelle

Les coûts annuels de propriété intellectuelle pour l'oragenics étaient de 412 000 $ en 2023, couvrant le dépôt, l'entretien des brevets et la protection juridique.

Catégorie de coûts IP	Montant ($)
Dépôt de brevet	185,000
Entretien de brevets	227,000

Coûts opérationnels de laboratoire

Les dépenses opérationnelles de laboratoire pour 2023 ont totalisé 1 675 000 $, y compris l'équipement, les fournitures et l'entretien des installations.

• Équipement de laboratoire: 892 000 $
• Fournitures consommables: 453 000 $
• Entretien des installations: 330 000 $

Dépenses administratives et personnel

Les dépenses administratives et du personnel total pour l'oragenics en 2023 étaient de 2 950 000 $.

Catégorie de dépenses	Montant ($)
Salaires et salaires	2,350,000
Avantages	425,000
Frais généraux administratifs	175,000

Oragenics, Inc. (OGEN) - Modèle d'entreprise: Strots de revenus

Licence potentielle de la technologie vectorielle bactérienne

Depuis le quatrième trimestre 2023, l'Oragénics n'a signalé aucun revenu de licence actif de sa technologie de vecteur bactérien. La valeur totale de licence potentielle reste non spécifiée.

Subventions de recherche et financement gouvernemental

Source de financement	Année	Montant
National Institutes of Health (NIH)	2023	$412,000
Grant de recherche sur l'innovation des petites entreprises (SBIR)	2022	$256,750

Future commercialisation des vaccins

Pas de revenus actuels de vaccins commerciaux en 2024. Développement continu des candidats vaccinaux.

Accords de recherche collaborative

• Valeur totale de l'accord de recherche en collaboration en 2023: 687 500 $
• Nombre de partenariats de recherche actifs: 2

Revenus potentiels de partenariat pharmaceutique

Pas de revenus de partenariat pharmaceutique signalés dans les états financiers de 2023. La valeur potentielle du partenariat reste non divulguée.

Revenus totaux pour Oragenics, Inc. en 2023: $1,356,250

Oragenics, Inc. (OGEN) - Canvas Business Model: Value Propositions

You're looking at the core of what Oragenics, Inc. (OGEN) is selling here-the unique benefits they promise to deliver to patients and the healthcare system with ONP-002. This isn't just another drug; it's a potential first-in-class intervention for a massive, underserved area.

Potential first FDA-approved pharmacological treatment for concussion.

The value proposition starts with being the pioneer. Oragenics, Inc. (OGEN) is actively working to bring what could be the first FDA-approved pharmacological treatment for concussion, specifically mild traumatic brain injury (mTBI). Honestly, the current landscape is bare; there are no FDA-approved pharmacological treatments currently available for concussion. That first-mover status is a huge part of the value.

Brain-targeted, non-invasive intranasal drug delivery.

The delivery method itself is a major differentiator. ONP-002 uses Oragenics, Inc. (OGEN)'s proprietary intranasal delivery system. This system is engineered to enable targeted, non-invasive delivery of therapeutics directly to the brain. In animal models, this intranasal route showed quick and significant distribution to all regions of the brain. Plus, they've developed a novel nanoparticle formulation that potentially increases drug percentage by 4-fold.

Here's a quick look at the advantages this delivery system aims to provide:

• Rapid onset and direct brain access.
• Non-invasive administration route.
• Excellent safety profile in animal studies.
• Low overall plasma levels compared to IV or oral routes.

Rapid access to the brain, minimizing systemic side effects.

Speed matters acutely after a head trauma. The clinical plan is aiming to administer the first dose within 8 hours of injury in Phase II human testing. By targeting the brain directly via the nasal passage, the drug is designed to interrupt the immediate biological cascade post-trauma, which preclinical models suggest reduces inflammation, oxidative stress, and brain swelling associated with concussion. Importantly, because ONP-002 is not a GABAergic compound, it does not cause fatigue.

Addressing significant unmet medical need in neurotrauma care.

The sheer scale of the problem underscores the unmet need. You can see the market size Oragenics, Inc. (OGEN) is targeting, which is a key component of the value proposition for investors and healthcare providers alike.

Metric	Value/Statistic
Global Concussion Market Estimate (by 2027)	$8.9 billion
Annual Concussions in the U.S. Alone	3.8 million
Annual Concussions Globally	Approximately 69 million
Percentage of TBI Classified as 'Mild'	Over 90%
Mild TBI Patients Not Fully Recovered by 6 Months	Over 50%
Population Developing Post-Concussion Syndrome (PCS)	Approximately 20%

To be fair, the burden extends beyond the initial injury. In the U.S. alone, TBI resulted in approximately 70,000 deaths in 2021 and leads to about half-a-million permanent disabilities each year. The value proposition is offering a treatment that could potentially prevent the chronic neurological diseases linked to these acute events, like Post-Concussion Syndrome (PCS). Finance: draft 13-week cash view by Friday.

Oragenics, Inc. (OGEN) - Canvas Business Model: Customer Relationships

You're a seasoned analyst looking at how Oragenics, Inc. (OGEN) manages its external relationships, which is critical for a clinical-stage biotech. Their customer base isn't selling widgets; it's composed of investigators, regulators, and capital providers. The relationships here are about trust, transparency, and execution on clinical milestones.

High-touch engagement with clinical investigators and key opinion leaders

Engagement with the medical and research community is centered on advancing the ONP-002 program for concussion. This involves securing top-tier partners for trial execution and manufacturing. Oragenics, Inc. has established the critical operational infrastructure for its Phase IIa trial in Australia, which is designed to assess feasibility, safety, tolerability, blood biomarker response, and pharmacokinetics/pharmacodynamics of ONP-002 in adults with mild traumatic brain injury (mTBI).

The structure of this high-touch relationship is defined by specific contracts and trial parameters:

• Human Research Ethics Committee (HREC) approval secured in Q2 2025.
• Southern Star Research appointed as the Clinical Research Organization (CRO).
• Sterling Pharma Solutions contracted for cGMP manufacturing at their Cary, North Carolina facility for planned Phase IIb trials.
• The Phase IIa study is designed to enroll up to 40 participants across two treatment arms.
• Participants are anticipated to receive a total of nine doses over five days.

This focused engagement is meant to support the goal of advancing ONP-002 toward becoming the first FDA-approved pharmacological treatment for concussion.

Transparent investor relations via shareholder updates and SEC filings

For investors, Oragenics, Inc. maintains communication through regular SEC filings and shareholder updates, a necessity given their development-stage status and recent capital activities. The company's commitment to transparency was highlighted by regaining full compliance with NYSE American's continued listing standards on October 20, 2025, resolving a stockholder equity deficiency where equity was restored above the $6.0 million threshold.

The financial context of these relationships, as of late 2025, shows significant activity aimed at funding clinical development:

Metric	Value as of Sep 30, 2025	Context/Period
Net Loss	$3.07 million	Three months ended Sep 30, 2025
Year-to-Date Net Loss	$7.56 million	Nine months ended Sep 30, 2025
Cash and Equivalents	$11.4 million	As of Sep 30, 2025
Gross Proceeds from July 2025 Financing	$16.5 million	Series H Convertible Preferred Stock
Debt Repaid in Q3 2025	$3.0 million	Short-term note
Accumulated Deficit	$224.3 million	As of Sep 30, 2025

The stock performance reflects market sentiment around these milestones; on December 2, 2025, the price was $0.85, contrasting sharply with its 52-week high of $18.90.

Direct communication with regulatory bodies (FDA, HREC)

Direct interaction with regulatory bodies is a non-negotiable part of the business. Oragenics, Inc. has been actively managing submissions to both Australian and U.S. authorities. The company submitted the Investigator's Brochure (IB) package for the Australian Phase IIa trial in Q1 2025. Furthermore, the IND package submission for the U.S. Phase IIb clinical trials is targeted for Q3 of 2025. This proactive regulatory engagement is essential to maintain the timeline for the planned Phase IIa trial initiation in Q4 2025/Q1 2026.

Future strategic relationships with potential pharmaceutical licensees

To build out its platform beyond the lead candidate, Oragenics, Inc. is establishing relationships that leverage technology for future asset development, signaling a move toward a multi-asset company. These are relationships with potential partners who could license or co-develop future assets.

Key strategic collaborations formalized in 2025 include:

• A collaboration with Receptor.AI in October 2025 to use artificial intelligence modeling to identify optimal receptor binding profiles for molecules acquired in 2023.
• A partnership with BRAINBox Solutions established in Q1 2025 to combine diagnostic biomarkers with the ONP-002 intranasal delivery system.

The company sees its proprietary intranasal delivery technology as having applications beyond concussion, positioning these AI and diagnostic partnerships to systematically explore those opportunities.

Oragenics, Inc. (OGEN) - Canvas Business Model: Channels

You're looking at how Oragenics, Inc. gets its critical operational and financial needs met, which is all about external partners and direct stakeholder outreach. For a clinical-stage company like Oragenics, Inc., these channels are less about selling a product and more about executing trials and securing capital to keep the lights on and the science moving.

Clinical Research Organizations (CROs) for trial management represent a key channel for executing the ONP-002 program. Oragenics, Inc. formalized this by selecting Southern Star Research as its CRO for the upcoming Phase IIa clinical trial of ONP-002 in Australia on July 31, 2025. This selection followed the securing of Human Research Ethics Committee (HREC) approval in Q2 2025. The company was actively working on protocol amendments post-HREC approval as of the Q3 2025 update, with Phase IIa trial initiation anticipated in Q3 2025. This operational channel is supported by a manufacturing agreement with Sterling Pharma Solutions in Cary, North Carolina, for cGMP production.

The Regulatory submissions (IND, IB) to health authorities channel is managed through direct interaction and submission packages. Oragenics, Inc. targeted the submission of the Investigator's Brochure (IB) package for the Australia Phase IIa clinical trials by Q1 2025. Furthermore, the company was targeting the submission of the Investigational New Drug (IND) package to the FDA for Phase IIb clinical trials in the US for Q3 of 2025. These submissions are the formal communication channel to the FDA to gain approval for trial expansion.

Financing, channeled through investment banks and placement agents for public offerings, has been active in 2025. While the company announced the expiration of its prior investment banking engagement agreement in February 2024, recent capital activity shows reliance on placement agents or direct offerings. The July 2025 Series H Convertible Preferred Stock and Warrants offering was a significant event, raising $16.5 million in gross proceeds, netting approximately $15.2 million after fees. This followed an earlier capital raise in Q1 2025, which brought in about $5 million in total funding.

Here's a quick look at the recent capital inflow through these channels:

Financing Event/Source	Date/Period	Gross Proceeds (USD)	Net Proceeds (USD)
Series H Convertible Preferred Stock & Warrants Offering	July 2025	$16,500,000	~$15,200,000
ATM Equity Sales (Q1 2025 component)	Q1 2025	$2,600,000 (Equity portion)	Not specified separately
Non-Dilutive Debt Funding (Q1 2025 component)	Q1 2025	$2,250,000 (Debt portion)	Not specified separately

For Direct-to-investor communication via corporate website and press releases, Oragenics, Inc. uses these platforms to manage market perception and report compliance status. A major communication point was the announcement on October 21, 2025, that the company had regained full compliance with NYSE American's continued listing standards, resolving a stockholder equity deficiency. The Q3 2025 Shareholder Update was issued on November 12, 2025, detailing operational progress. Investor awareness efforts also included participation in industry events, such as the 12th Annual Brain Health Summit at Leigh Steinberg's Super Bowl Party 2025 in Q1 2025.

Key investor communication touchpoints include:

• Regained full NYSE American compliance on October 20, 2025.
• Reported 30% reduction in research and development expenses year-over-year for the nine months ended September 30, 2025.
• Announced $11.4 million in cash and cash equivalents as of September 30, 2025.
• Formalized a strategic collaboration with Receptor.AI in Q3 2025.
• Reported a net loss of $3.06 million for the three months ending September 30, 2025.

Finance: draft 13-week cash view by Friday.

Oragenics, Inc. (OGEN) - Canvas Business Model: Customer Segments

You're looking at the core groups Oragenics, Inc. (OGEN) targets to fund its development and ultimately deliver its ONP-002 therapy. For a clinical-stage biotech, these segments are not just users; they are the lifeblood of the operation.

Institutional and retail investors providing development capital

This group provides the necessary fuel for the ONP-002 Phase IIa trial in Australia and preparation for U.S. Phase IIb trials. You need to know their recent commitment levels. In Q3 2025, the company executed a significant capital raise, bringing in approximately $16.5 million in gross proceeds via Series H Convertible Preferred Stock and Warrants. This followed an earlier Q1 2025 raise of about $5 million. Honestly, these financing activities are critical, especially since the company reported a net loss of $3.06 million for the three months ending September 30, 2025, and continues to operate without revenue. As of September 30, 2025, the cash position stood at $11.4 million, projected to fund operations through the first half of 2026, despite an accumulated deficit of $224.3 million. The ownership structure shows that institutional investors hold approximately 2.56% of the stock as of September 2025, with a total of 5 identified institutional investors.

Here's a quick look at the financial context supporting this segment:

Financial Metric	Amount as of Late 2025 Data Point	Date/Period
Gross Capital Raised (July 2025)	$16.5 million	Q3 2025
Net Cash from Financing Activities (Q3 2025)	$12.41 million	Q3 2025
Cash and Cash Equivalents	$11.4 million	September 30, 2025
Accumulated Deficit	$224.3 million	September 30, 2025
Institutional Ownership Percentage	2.56%	September 2, 2025

Regaining full compliance with NYSE American listing standards in October 2025, after resolving a stockholder equity deficiency, was a key action to maintain appeal for this segment.

Patients with mild Traumatic Brain Injury (mTBI) or concussion

This is the ultimate beneficiary group for ONP-002. The market need is substantial, given that 3.8 million concussions happen annually in the United States alone. Furthermore, a persistent issue is that about 20% of those affected can remain symptomatic for months or years, developing Post-Concussion Syndrome (PCS). Oragenics is actively engaging this population through clinical trials. The HeadSMART II trial, in collaboration with BrainBox Solutions, is one of the largest U.S. emergency department biomarker discovery studies for mTBI and is expected to enroll over 2,000 patients within the next year. The company believes early treatment could prevent chronic brain disorders resulting from mTBI.

Consider the scale of the target market:

• Annual US Concussions: 3.8 million
• Estimated Global Concussion/mTBI Market Value: $8.9 billion by 2027
• Population with Persistent Symptoms (PCS): Approximately 20% of mTBI patients
• HeadSMART II Trial Enrollment Target: Surpass 2,000 patients

The goal is to bring ONP-002 to market as the first FDA-approved pharmacological treatment for concussion, where currently none exist.

Neurologists, neurotrauma specialists, and emergency clinicians

These clinicians are the gatekeepers for acute treatment and trial participation. They need a therapy that is effective, safe, and easy to administer in high-stress environments like the Emergency Room (ER). ONP-002 is being developed for use in the acute ER setting, with a proposed regimen of 2X a day for 5-days post brain injury. The intranasal delivery system is designed to bypass the blood brain-barrier, showing quick and significant distribution to all brain regions in animal studies. The Phase IIa trial in Australia is moving forward, with protocol amendments submitted to analyze cognitive, visual motor, and patient-reported outcomes, which are key metrics for these specialists. The collaboration with BRAINBox Solutions aims to create a test-to-treat platform, which appeals directly to clinicians seeking faster, more targeted care based on diagnostic biomarkers.

Future pharmaceutical companies for licensing or acquisition

This segment represents a potential exit or major partnership event, which drives significant shareholder value. As of June 2025, Oragenics, Inc. explicitly listed ONP-002 for mTBI (concussion) and ONP-001 for various rare leukodystrophies as unlicensed products looking for licensing opportunities. The company is actively building value inflection points, such as the initiation of the ONP-002 Phase 2a clinical study by the end of Q2 2025. Furthermore, Oragenics formalized a strategic collaboration with Receptor.AI in Q3 2025 to accelerate the development of its expanded molecule portfolio beyond ONP-002, signaling an intent to build a broader neurological therapeutics platform attractive for in-licensing or acquisition. The company's proprietary intranasal delivery technology itself is a key asset, positioned in a nasal drug delivery market projected to exceed $40 billion by 2030.

Oragenics, Inc. (OGEN) - Canvas Business Model: Cost Structure

You're looking at the core spending areas for Oragenics, Inc. (OGEN) as they push their pipeline forward, especially with ONP-002. For a development-stage biopharma, the cost structure is heavily weighted toward science and compliance.

Research and Development (R&D) expenses, totaling $1.7 million for the nine months ended Q3 2025, show a strategic shift. This is down from $2.4 million in the same period of 2024, suggesting a pivot toward regulatory filings and manufacturing readiness rather than pure discovery work. Still, R&D remains a major cash burn item.

Selling, General & Administrative (SG&A) expenses were approximately $6.83 million for the Trailing Twelve Months (TTM) ending September 2025. For just the third quarter of 2025, General and Administrative (G&A) expenses specifically climbed to $2.2 million, up from $1.6 million in Q3 2024. This quarterly jump was mainly due to higher legal and professional fees, including significant accruals related to a legal settlement.

Here's a quick look at the major reported operating expenses as of late 2025:

Cost Component	Period	Amount (USD)
Research and Development (R&D)	Nine Months Ended Q3 2025	$1.7 million
Selling, General & Administrative (SG&A)	TTM Ended Sep '25	$6.83 million
General and Administrative (G&A)	Q3 2025	$2.2 million
R&D	Q3 2025	$930,894

Clinical trial costs are an embedded, and growing, part of the R&D spend. The company secured infrastructure for Phase IIa trials in Australia, which means significant future outlays for Contract Research Organization (CRO) fees and site payments are definitely on the horizon. You have to assume these costs are baked into the R&D budget until they are separately broken out.

Manufacturing and supply chain costs for drug-device units, particularly for the ONP-002 intranasal therapy, are ramping up. The reported decrease in R&D for the nine-month period is explicitly linked to a strategic pivot towards manufacturing readiness. This signals a necessary, non-negotiable cost increase as the company moves closer to potential commercialization.

Public company compliance and legal fees are a visible pressure point in the SG&A line. The increase in G&A for Q3 2025 was primarily driven by higher legal and professional fees, including accruals for a legal settlement. Furthermore, the company noted rising costs associated with patent-related legal expenses and investor relations as part of the nine-month G&A increase. The fact that Oragenics, Inc. announced regaining NYSE American compliance in late 2025 suggests that resolving prior listing deficiencies also involved specific, non-recurring professional service costs.

The key cost drivers you need to watch are:

• Higher legal and professional fees impacting G&A.
• Costs associated with patent defense and maintenance.
• Ramping up manufacturing readiness expenses.
• Future CRO and site payments for planned Phase IIa trials.

Oragenics, Inc. (OGEN) - Canvas Business Model: Revenue Streams

You're looking at a clinical-stage company, so the first thing to understand about Oragenics, Inc. (OGEN)'s revenue streams is what's missing: sales. As of late 2025, Oragenics, Inc. (OGEN) has effectively zero revenue from product sales. This is the reality for a company deep in development, meaning its financial lifeblood comes from elsewhere until a drug like ONP-002 gets that final FDA sign-off. For the first three quarters of the 2025 fiscal year (Q1, Q2, and Q3), Oragenics, Inc. reported $0 in Total Revenue across the board. The Trailing Twelve Months (TTM) revenue ending September 30, 2025, was also reported as approximately $0.0 million.

Because the company is operating at a loss-reporting a net loss of $10.9 million for the TTM ending September 30, 2025-its primary, immediate source of cash to fund operations, like the ONP-002 clinical trials, is financing activities. This is how you bridge the gap between discovery and market. The most significant recent infusion was the July 2025 public offering of Series H Convertible Preferred Stock and Warrants. This transaction brought in net proceeds of approximately $15.2 million after accounting for placement agent fees and other estimated expenses. This capital was earmarked to advance the ONP-002 Phase IIa trials, repay debt, and fund working capital.

To give you a clearer picture of how Oragenics, Inc. (OGEN) has been funding its operations, here's a look at the key financing events that serve as its current revenue substitutes:

Financing Event	Date	Gross Proceeds (Approximate)	Net Proceeds (Approximate)	Security Type
Public Offering	July 2025	$20.00 million	$15.2 million	Series H Convertible Preferred Stock and Warrants
ATM Agreement Sales	February 2025	N/A	$2.6 million	Common Stock

The structure of the July 2025 financing is important to note; the Preferred Stock is convertible into common stock at a price of $2.50 per share, which carries the risk of future dilution. Still, this capital restored stockholder equity above the $6 million threshold, allowing Oragenics, Inc. (OGEN) to regain compliance with NYSE American listing standards on October 20, 2025.

Looking further out, the potential for non-operating revenue is tied directly to the success of its pipeline and any existing partnerships. You should keep an eye on milestone payments and royalties, which represent the true long-term revenue potential for a company like this. For instance, Oragenics, Inc. (OGEN) has a licensing agreement with Norgine for PEDMARQSI, which includes potential future payments. This agreement has the potential to yield up to an additional $230 million in milestone payments and tiered royalties, on top of the $43 million upfront payment already received in March 2024. The company also mentioned in its Q2 2025 update that its focused approach may position it to achieve a successful drug development milestone, which often triggers payments under such agreements.

The expected future revenue streams for Oragenics, Inc. (OGEN) are entirely contingent on clinical and regulatory success:

• Zero revenue from product sales, as a clinical-stage company.
• Primary source is equity financing, like the $15.2 million net proceeds from the July 2025 public offering.
• Potential future milestone payments from licensing agreements, such as the Norgine deal.
• Potential future royalties or product sales post-FDA approval for ONP-002.

The company's ability to secure funding remains pivotal as it navigates the complex landscape of biopharmaceutical development. Finance: review the cash runway projections based on the $15.2 million net inflow against the Q3 2025 operating cash burn rate by next Tuesday.